Implantable devices, such as a pacemaker ICD generator or a loop recorder, are often implanted into the human body to aid specific biological functions. When the device has served its usefulness, doctors often need to perform surgical procedures to remove the implanted device. Under certain circumstances, doctors may remove and replace parts of the implanted device, such as a battery, or components of artificial hips, artificial knees, spinal prosthetics, or components used in traumatic fracture repair, or tunneling tools and their accessories, rather than removing the implanted device itself.
Typically, when an implanted device is being removed, such as when a pacemaker generator is being removed, the general area where the implanted device is located is prepared with anesthetics. An incision is made in the skin and tissues and scar tissues around the device are resected. Sutures anchoring silicone covered leads or wires attached to the implanted device or anchoring the device itself are cut. Typically, these leads and wires are sutured into the bottom aspect of the open pocket, typically to the bottom side/inner edge of the pocket using the wire suture tabs sleeves, which wrap around the leads or wires. Sutures are generally not cut from the wire suture tab sleeves. Wires are only removed when there is a lead or wire fracture, or the lead or wire is infected, or when there is a manufacture recall on the product and the product needed to be explanted.
Once the device or generator is loosened from the scar tissue and is ready to be taken out, the clinician will need a tool to extract the generator or battery from the pocket.
Methods presently available generally involve the use of multiple surgical tools. A conventional method for extracting an implanted device is to cut the skin and fillet the skin to create a pocket to see the exact location of the implanted device. Once the pocket is opened, it is often kept open with a retractor such as a Weitlaner Retractor or equivalent. Doctors often have to over stretch the opening pocket in order to allow other tools, such as a sponge forceps, curved Kelley, or curved, straight or angled hemostats, or skin retractor to be inserted and used to extract the implanted device out of its implanted cavity.
There are several drawbacks associated with the conventional method. First, the opening pockets are stretched out unnecessarily to create an opening sufficient wide for the surgeon to see and pinpoint the exact location of the implanted device and for insertion of multiple surgical tools for extraction. Sutures that may or may not anchor the device to the opening pocket are cut in attempts to free the device. A Weatlander retractor stretches the pocket or cavity where the generator is recessed in. Once the pocket is held open by the Weatlander retractor, a sponge forceps, curved Kelley, hemostat or skin retractor is used to try and excavate the generator out of the pocket or cavity. Many attempts are made to explant the generator that has surrounding scar-tissue. Often, numerous attempts are made to grab the implanted device, with curved Kelleys, sponge forceps, hemostat or skin retractor and other surgical apparatus, causing the implanted device's casing to become marred, sometimes damaged. Furthermore, some of the apparatus used to extricate the device have raised edges or teeth. Those teeth can scrape small parts of metal into the tissue pocket from where the device is being extricated.
The tugging and manipulation of the implanted device to extract it from the body can also cause movement or dislodgment of implanted leads in the body or heart that are connected to the implanted device. This can increase the overall cost of a simple procedure, such as a generator replacement procedure, and compromise the safety of the patient. The cost can increase from a simple generator change to a dual lead revision and generator replacement.
Accordingly, it is desirable to provide an improved apparatus and method that overcome drawbacks and inadequacies of known devices and methods.